EP0527703B1 - Dispositif permettant de déterminer la concentration d'au moins un composé gazeux en particulier la teneur en oxygène du sang - Google Patents

Dispositif permettant de déterminer la concentration d'au moins un composé gazeux en particulier la teneur en oxygène du sang Download PDF

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Publication number
EP0527703B1
EP0527703B1 EP92810583A EP92810583A EP0527703B1 EP 0527703 B1 EP0527703 B1 EP 0527703B1 EP 92810583 A EP92810583 A EP 92810583A EP 92810583 A EP92810583 A EP 92810583A EP 0527703 B1 EP0527703 B1 EP 0527703B1
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EP
European Patent Office
Prior art keywords
light
sensor
light receiving
area
blood
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EP92810583A
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German (de)
English (en)
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EP0527703A1 (fr
Inventor
Rudolf Alexander Dr. Hatschek
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AVL Medical Instruments AG
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AVL Medical Instruments AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A61B2562/0242—Special features of optical sensors or probes classified in A61B5/00 for varying or adjusting the optical path length in the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array

Definitions

  • the invention relates to a device for measuring at least one gas saturation, in particular oxygen saturation, of blood present in a living body.
  • the device can also be designed to measure, in addition to the oxygen saturation or possibly instead of this, another gas saturation of blood - for example its carbon monoxide saturation.
  • the device should enable a non-invasive measurement.
  • non-invasive here means that the measurement is carried out without any instrument inserted into a blood vessel and therefore exclusively with sensor means that are completely outside the living, human or possibly animal body on which the measurement is carried out. In the intended uses of the device for measuring gas saturation, one usually wants to measure that of arterial blood.
  • the hemoglobins which are mainly present in the red blood cells of the blood, can bind, transport and release various gases - such as oxygen and carbon monoxide.
  • the blood may contain oxyhemoglobin, ie hemoglobin with bound oxygen, deoxyhemoglobin, ie hemoglobin without oxygen, and carbon monoxide hemoglobin.
  • Gas saturation is understood to mean a value which gives a measure of the concentration or the proportion of hemoglobin which contains the gas in question.
  • the oxygen saturation to be measured in particular can be a measure of the ratio between the concentration of the oxyhemoglobin and the concentration of the sum thereof as well as the deoxyhemoglobin or the total hemoglobin concentration.
  • the degree of saturation which is equal to the percentage value of the ratio mentioned, is often given as the measure of oxygen saturation.
  • the blood plasma and the red blood cells and other blood cells contained therein have different refractive indices, so that a light beam is normally deflected by refraction when it enters a blood cell formed, for example, by a red blood cell and when it exits from it.
  • the light can also be redirected by reflection and diffraction.
  • the entirety of all redirection processes is called scattering.
  • a beam of light shining into a blood vessel is usually scattered several times in the blood until it emerges from the blood vessel again. When the light passes through a red blood cell, part of the light is absorbed.
  • the bound oxygen-containing hemoglobin i.e. the oxyhemoglobin
  • the oxygenless hemoglobin i.e. that have deoxyhemoglobin
  • different colors and, accordingly, different light absorption spectra If the absorption coefficients of the two types of hemoglobin as a function of the light wavelength are represented by curves in the same diagram, the two curves cross each other at so-called isobestic points, for example at a wavelength which is referred to below as the isobestic wavelength and is approximately 805 nm.
  • Devices for the non-invasive measurement of a gas saturation of blood, in particular of its oxygen saturation are for example from the publication "A new noninvasive backscattering oximeter", TM Donahoe and RL Longini, Proceedings of the Seventh Annual Conference of the IEEE / Engineering in Medicine and Biology Society, 1985, Chicago, USA, volume 1, pages 144 to 147 , from US-A-4 890 619 and from GB-A-2 228 314.
  • These devices have sensor means, light radiation means in order to radiate light into a body to be examined in at least one light radiation region of the sensor means, and light receiving means. in order to receive light scattered in the body in at least one light receiving area of the sensor means and to measure its intensity with at least one photo semiconductor.
  • the known devices also have electronic switching means to determine the oxygen saturation and possibly other variables from the light intensities determined by the photo semiconductors.
  • the from the cited publication by Donahoe et al. known device has two identical sensors. Each of these has two light-emitting diodes which form light sources for generating light with two different wavelengths and which together define a light radiation region on the side of the sensor which is in contact with the body to be examined, through which the generated light can be radiated into the body. Each sensor also has light receiving means with two light receivers each consisting of a phototransistor. The two phototransistors are in a plan view of the side of the sensor intended for contact with the body at different distances from a straight line running through the two light-emitting diodes and each define a light receiving area through which light scattered back in the body can reach the relevant phototransistor.
  • the one sensor provided for measuring the oxygen saturation of the arterial blood is replaced with a sensor present in it Heating coil heated, while the other sensor is not heated and should measure the oxygen saturation of the tissue.
  • the devices known from the already cited US-A-4 890 619 also have two identically designed sensors, each of which has a light receiver formed by a photodiode and four or six light-emitting diodes arranged on a circular line surrounding the latter.
  • the light-emitting diodes of each sensor form light sources for generating light with two different wavelengths and together define an annular light radiation area in which light can be emitted from the sensor.
  • the distance of the light receiving area defined by the photodiode of the relevant sensor from the annular light radiation area is approximately equal to the mean radius of the latter.
  • Some of the sensors still have ultrasound sources for heating the tissue by means of ultrasound.
  • the devices known from US-A-4 890 619 make it possible to measure the oxygen saturation depending on the arrangement of the two sensors with transmission light penetrating the body, passing from one sensor to the other sensor, or with backscattered light which is scattered back from the body into the same sensor from which it was broadcast.
  • GB-A-2 228 3144 discloses a device which is designed, inter alia, to measure the oxygen saturation of the blood present in the brain.
  • the light radiation means of the device have a number of laser diodes which can produce light with different wavelengths for the measurement of the oxygen saturation. Each laser diode is connected to the entry end of an optical fiber, the exit end of which is located on the surface of the head of a patient to be examined.
  • the light receiving means of the device have a number of light guides with it on the surface of the head of the patient's entry ends. In the device described above, the light guides of the light receiving means all lead from the head to one and the same photodetector.
  • the outlet ends of the light guides belonging to the light radiation means and the entry ends of the light guides belonging to the light receiving means are more or less uniformly distributed over the upper half of the head of the person to be examined.
  • the device therefore has a multiplicity of light radiation regions and light reception regions, the light radiation regions and the light reception regions alternatingly following one another from a top view viewed vertically from above along the circumference of the head. For the rest, there are relatively large gaps between the light radiation areas closest to each other as well as between the light reception areas closest to each other.
  • light is sequentially radiated through the skull into the brain in the different light radiation areas.
  • this light which is scattered and again radiated out of the head through the skull, it can then be collected at the various light receiving areas. If, for example, light is radiated into the head at a light radiation point located at the "equator" of the head, scattered light can be collected at each light receiving point which, depending on the position of the light receiving point concerned, has been scattered back, scattered to the side or forward scattered.
  • the intensity of the light scattered by red blood cells and entering a light receiver through a light receiving area when measuring with backscattered light depends on the distance of the light receiving area measured along the body surface from the light radiation area at which the light was radiated into the body. As will also be explained in more detail, the most favorable value of this distance depends on the individual anatomical properties of an examined person, on the body location selected for measurement and also on the current physiological state of an examined person, which is subject to temporal changes.
  • the devices known from the various publications cited therefore have the disadvantages when measuring with backscattered light that the achievable measurement accuracy can change from measurement to measurement and that considerable measurement errors sometimes occur.
  • the devices known from US-A-4 890 619 are used for measuring with transmission light, they have, in addition to more or less similar disadvantages as for measuring with backscattered light, the main disadvantage that the measurements only take place on thin parts of the body, such as one Earlobes or fingers can be done.
  • measurements with transmission light are relatively poorly suited for long-term, continuous monitoring because, for example, movements of the person being examined frequently result in measurement errors cause.
  • the same also applies to measurements with the devices according to GB-A-2 228 314. Since the light has to penetrate twice the bone parts of the skull when these devices are operated, the measurable light intensities are also very low, which further impairs the measuring accuracy.
  • the radiation intensities of the various light-emitting or laser diodes or the sensitivity of the photo semiconductors change over time, this can also impair the measuring accuracy.
  • measurement inaccuracies can occur if the radiation intensity changes differently at the different wavelengths or if the spectral sensitivity of a photo semiconductor changes.
  • the oxygen supply to tissues and / or organs of a living being depends not only on the oxygen saturation of the blood, but also on the intensity of the blood perfusion, i.e. the blood flow.
  • the blood perfusion cannot be measured, or at most with little accuracy.
  • the object of the invention is therefore to create a device for measuring at least one gas saturation of blood - in particular its oxygen saturation - which overcomes the disadvantages of the known devices.
  • the aim is to achieve the greatest possible measurement accuracy when measuring, regardless of the individual anatomical properties of the body of a living being examined, regardless of the location of the body selected for the measurement and regardless of physiologically-related changes in state.
  • the scattering of the scattered light which is desired for the determination of gas saturation - in particular oxygen saturation - and changes periodically in time with the pulse frequency takes place predominantly in the arteries present in the middle and / or lower dermis.
  • the intensity of scattered light which was scattered exclusively during scattering processes in the skin layers above the arteries, is predominantly constant over time and / or changes only more or less stochastically over time.
  • the scattered light with a temporally constant and / or stochastically changing intensity can be understood as the effect of background scattering and / or physiological noise and can be referred to as background and / or noise backscattering light.
  • the intensity, composition and direction of the scattered light emerging from the skin surface depends on the thickness, the structure and the absorption properties of the various skin layers, the hematocrit value and the blood circulation.
  • the hematocrit value is the ratio between the volume of red blood cells and the volume of whole blood. Regarding the hematocrit value, it should also be noted that this is usually given in percent, typically is approximately 42%, but can vary between 20% and 60%.
  • the scattering taking place in the skin was investigated with a model calculation and experimentally for a sharply bundled bundle of light rays that were emitted into the skin at a point-like point of light radiation.
  • the skin was divided into four layers with different scattering and absorption properties.
  • Different models were used in the model calculations.
  • each layer was represented by a flat surface and a mathematical function that assigned a retroreflective intensity to every point on the surface.
  • the intensity of the light scattered in the middle and / or deeper layer of the dermis and also the ratio between this intensity and the intensity of the total scattered light increase with increasing distance of the light receiving area from the light radiation area and then decrease again.
  • the intensity of the light scattered in the middle and / or deeper layer of the dermis and the relationship between this intensity and the intensity of the entire scattered light therefore have a maximum at a certain distance from the light radiation region.
  • the investigations further showed that the distances between these maxima of the intensity of the light scattered in the middle and / or lower layer of the dermis from the layer thicknesses, the depths of the arteries, the scattering and absorption properties of the various layers and from Hematocrit value are dependent. Since the scatter and absorption also depend on the blood circulation, ie on the volume of the blood present in the examined body section, the location of the maxima can also depend on the blood circulation. Since the thicknesses of the various skin layers, the scattering and absorption properties as well as the hematocrit value can vary from individual to individual, depend on the body part chosen for measurement and can even change in part in time, so are the distances at which these are mentioned Maxima occur differently.
  • the device therefore has a sensor with a plurality of light receiving areas in which the light intensities can be measured separately.
  • the light receiving areas In a plan view of the side of the sensor intended to be in contact with a living body and thus during measurement along the surface of the body to which the sensor lies, the light receiving areas have measured different distances from the light radiation area of the sensor.
  • the device according to the invention also has circuit means, namely electronic circuit means, which, when measuring, select at least one favorable light-receiving region as the utilization region on the basis of a predetermined selection criterion.
  • the circuit means which have, for example, a microprocessor, can be designed, for example, to determine the pulse frequency and to use the part of the scattered light which changes periodically in time with the latter for determining the gas saturation - for example the oxygen saturation - of the hemoglobins of the arterial blood.
  • the circuit means can then, for example, determine the gas saturation from the light intensities measured in the light receiving range at which the stroke and thus also the amplitude of the light intensity changing in time with the heartbeats is greatest for one of the light wavelengths used or at which the ratio between of said amplitude and the intensity of the total scattered light having said wavelength is greatest.
  • the 1 shows a piece of the skin 3 belonging to a body 1 of a patient.
  • This consists of the vesselless epidermis 5 and the dermis 6 containing blood vessels.
  • the epidermis 5 can be divided into at least two layers, namely the cornea and the germ layer, of which the cornea consisting of dead cells forms the surface of the body 1.
  • the outer or upper layer of the dermis 6 contains the smallest blood vessels which enable microcirculation, namely arterioles 9, venules 10 and capillary loops 11.
  • the arterioles 9 and venules 10 are with larger arteries lying in the middle and / or deeper layer of the dermis 6 13 and veins 14 connected.
  • the dermis also contains arteriovenous anastomoses 15, which form controllable connections between an arteriole and a venole, serve to control the blood flow and, in the open state, can bridge the capillary vessels connected to the arteriole or venole in question.
  • arteriovenous anastomoses 15 which form controllable connections between an arteriole and a venole, serve to control the blood flow and, in the open state, can bridge the capillary vessels connected to the arteriole or venole in question.
  • the 1 also shows a device designated as a whole as 21 for measuring at least one gas saturation of blood, namely at least the oxygen saturation of blood.
  • the device 21 has sensor means with one and only one sensor 23, which is brought into contact with the surface of the skin 3 when it is used.
  • the sensor can optionally be arranged on a variety of different parts of the body.
  • the sensor 23 can be detachably fastened to the skin 3 with fastening means not shown, for example with at least one adhesive strip.
  • the essentially dimensionally stable sensor 23 which is also shown separately in FIG. 2, has a housing 25 which, for example, has approximately the shape of an elongated cuboid, but could have rounded transitions instead of edges.
  • the housing 25, which is made of plastic, for example, is open on its side facing the skin 3 during measurement and there has a peripheral housing edge 25a which defines a flat surface. The case is closed everywhere on the other sides.
  • Light radiation means 27 and light receiving means 29 are arranged in the housing.
  • the light radiation means 27 have several - namely three - light sources 31. These are formed by semiconductor diodes, that is to say by light-emitting diodes to produce “ordinary” light, or at least in part by laser diodes to produce spatially and temporally coherent light and can consist, for example, of GaAlAs diodes.
  • Each of the three semiconductor diodes has a light point facing the skin 3 and generates a light beam during operation, the opening or cone angle of which, for example, is at most about 10 ° and whose diameter at the light point of the diode is, for example, at most or about 0.2 mm.
  • Each of the three light sources 31 or diodes can generate at least approximately monochromatic and, for example, coherent light in pulses. However, the three light sources 31 are designed to generate three different types of light, each of which has a different wavelength.
  • the three light sources 31 are referred to below as first, second and third light sources, this numbering being able to correspond, for example, to the sequence counted from top to bottom in FIG. 2, but this need not be the case.
  • the first light source can generate light with a wavelength close to the isobestic wavelength, for example approximately 800 to 830 nm.
  • the other two light sources can then generate types of light whose wavelengths are at least 100 nm different from the isobestic wavelength, namely smaller than this.
  • the second light source can preferably generate light whose wavelength is in the range from approximately 620 nm to 750 nm, in which the absorption coefficients of oxyhemoglobin and deoxyhemoglobin are very different from one another.
  • the second light source can generate light with a wavelength of approximately 660 nm.
  • the third light source can then generate light whose wavelength is in the range from about 500 nm to 600 nm, in which both oxyhemoglobin and deoxyhemoglobin and, incidentally, also hemoglobin with bound carbon monoxide give a relatively large absorption.
  • the wavelength of the light generated by the third light source can be, for example, approximately 575 nm.
  • the three light sources 31 or semiconductor diodes each consist of a separate component and are arranged as close as possible to one another in a straight row, so that they touch each other at least approximately in pairs. Otherwise, the light sources 31 have, for example, a generally quadrangular, namely rectangular, outline shape, the longer sides of the rectangle being perpendicular to a straight line 37 perpendicular to the longitudinal direction of the housing 25.
  • the light-emitting means 27 also have light-guiding means 33 which consist of a platelet-shaped body which is common to all light sources 31 and is described in more detail.
  • the light-guiding means 33 have a flat light entry surface facing the light sources 31 and adjoining them, and a flat light exit surface which is at least approximately and namely exactly in the plane spanned by the edge 25a of the housing 25.
  • the three light sources 31 each define a light radiation point 34 at which the light generated during operation by the light source in question is emitted from the sensor and which, for example, consists of a small, ring-shaped, almost point-like field.
  • the three light radiation points 34 are enveloped by an envelope line, approximately one rectangular light radiation area 35 limited.
  • the center points of the light radiation points 34 defined in the above plan view by the three semiconductor diodes 32 lie on the straight line 37.
  • the center point of the middle light radiation point 34 also forms the center point of the entire light radiation region 35.
  • the dimensions of the light sources 31 measured along the straight line 37 and the distances between the light sources 31 Centers of the adjacent light radiation points 34 are preferably at most 2 mm and, for example, approximately 1 mm to 1.5 mm.
  • the extent of the light radiation region 35 measured along the straight line 37 is accordingly at most 6 mm and preferably at most as 5 mm.
  • the extent of the light radiation region 35 measured at right angles to the straight line 37 is at most 2 mm, preferably at most 1 mm and, for example, less than 0.5 mm.
  • the light receiving means 29 have several, namely at least three, preferably at least five and for example up to about twenty light receivers 41 arranged in a straight row, seven light receivers being drawn for the exemplary embodiment. These consist of separate, identically designed photo semiconductors, namely silicon photodiodes.
  • the light receiving means 29 are equipped with light guide means 43, which consist of a plate-like body common to all light receivers 43, which forms a multiple light guide and non-imaging collimator assigned to each light receiver.
  • the light guide means 43 have a flat light entry surface, which lies at least approximately and namely exactly in the plane spanned by the edge 25a of the housing 25, and a flat light exit surface which faces the light entry sides of the light receivers 41 and bears against them.
  • the light receivers 41 are arranged alongside one another along the row formed by them at least approximately without gaps. Each light receiver 41 defines in a plan view in one that is in contact with the body during measurement On the side of the sensor and thus in the light entry surface of the light guide means 43, a light inlet field 44, in which light can pass through the light guide means 43 into the relevant light receiver, so that this light receiver can then measure the intensity of this light.
  • the light inlet fields 44 form a straight row and have center points lying on a straight center line 47.
  • the center line 47 runs parallel to the longitudinal direction of the housing 25 and at right angles to the straight line 37 through the center of the central light radiation point 34 and the entire light radiation region 35.
  • the light inlet fields 44 have, for example, a generally square and namely rectangular outline shape, the longer sides of the rectangle parallel to the straight line 37 are. Otherwise, the light inlet fields 44 of the light receivers which are adjacent to one another in pairs follow one another at least approximately without gaps. Depending on the design of the housing and the light entry sides of the light receivers 41, however, small gaps - ie surface sections - may exist between the light inlet fields 44 which are adjacent to one another in pairs, in which the light impinging on them does not reach any of the light receivers. However, the extent of each light inlet field 44 measured in the longitudinal direction of the row of light receivers should be more than half and preferably at least two thirds of the distance between the centers of adjacent light inlet fields 44. Each of these serves as a light receiving field 45, in which, during operation, the intensity of the light scattered back in the body 1 and re-entering the sensor can be measured separately.
  • the various light inlet fields 44 and the light receiving areas 45 which are identical to these have different distances from the light radiation points 34, the light radiation area 35 containing them and those passing through the centers of the light radiation points 34 Straight line 37. It should be noted that these distances are measured perpendicular to the central axes of the light beams emitted from the sensor 23 at the light radiation points 34 and parallel to the plane in which the light radiation points 34, the light radiation area 35 and the light receiving areas 45 are located.
  • the distance of the center of the light inlet area 44 or light receiving area 45 closest to the light radiation area 35 from the straight line 37 and from the center of the light radiation area 35 is preferably at least 4 mm, preferably at most 10 mm and for example about 7 mm.
  • the dimensions of the light receivers 41 and light inlet fields 44 measured parallel to the straight line 47 and the distances between the centers of adjacent light inlet fields 44 or light receiving areas 45 are preferably at most 3 mm and for example 1.5 mm to 2.5 mm.
  • the distance of the center of the light inlet field 44 or light receiving region 45 furthest from the light radiation points 34 from the straight line 37 and from the center of the light radiation region 35 is preferably at least 15 mm and for example 18 mm to 30 mm.
  • the dimension - ie length - of each light inlet field 44 measured parallel to the straight line 37 is preferably approximately or at least equal to the dimension of the light radiation region 35 measured in the same direction, ie the row formed by the three light radiation locations 35.
  • the two platelet-shaped bodies forming the light guide means 33 and 43 have approximately or exactly the same outline shapes and outline dimensions as the group of light sources 31 and the group of light receivers 41 in the plan view drawn in FIG. 2. Otherwise, the light guide means 33 and 43 apart from their different outline shapes and outline dimensions, the same or similar.
  • the light-guiding means have a number of flat, mutually parallel disks 51 rectangular to the straight line 47 with a rectangular outline.
  • the areas of the disks 51 on the broad sides thereof are designated 51a.
  • the disks 51 following one another along the straight line 47 are firmly connected to one another by layers 53 arranged between the mutually facing surfaces 51a of a pair of disks.
  • the discs 51 have flat edges at all edges, perpendicular to the plane of the discs.
  • the panes 51 are crystal clear and translucent as well as possible for the three types of light generated and consist, for example, of mineral glass.
  • the flat edge surfaces of the panes 51 of the light guide means 33 facing the light sources 31 together form the light entry surface of the latter.
  • the flat edge surfaces of the panes 51 of the light guide means 33 facing away from the light sources 31 together form their light exit surface, which contain the light radiation points 34 and the light radiation region 35.
  • the diameters of the light beams generated by the light sources 31 are significantly smaller than the dimensions of the light guide means 33 measured parallel to the straight line 47, so that only a part of the disks 51 belonging to them or even only a single disk 51 the light guide means 33 is actually light passed through.
  • the edge surfaces of the panes of the light guide means 43 facing away from the light receivers 41 together form their light entry surface, the light inlet fields 44 and the light receiving areas 45.
  • the edge surfaces of the panes of the light guide means 43 facing the light receivers 41 form their light exit surface.
  • the layers 53 are formed from a material which consists at least in part of an adhesive which is more or less is less translucent and has a smaller refractive index than the glass forming the panes 51.
  • the adhesive can be formed, for example, by a two-component adhesive, one component of which is made of an epoxy resin.
  • those layers 53 which form the boundary between different light inlet fields 44 may still contain highly light-absorbing particles dispersed in the epoxy resin forming a transparent matrix. If necessary, all layers 53 of the light guide means 33 and 43 can even contain such particles. These increase the light absorption of the layers 53 and make them more or less opaque.
  • the surfaces 51a of the panes 51 located on the opposite ends of the rows of panes of the light guide means 33, 43 and the edge faces 51b of the panes 51 at right angles to the light entry surfaces and the light exit surfaces of the light guide means 33, 43 can also be coated be provided, which consists of the same material as the layers 53.
  • the last-mentioned edge surfaces of the panes with a coating which results in a mirror coating and consists, for example, of a vapor-deposited metal layer.
  • the light guide means 33, 43 are electrically insulating.
  • each pane 51 measured parallel to the straight line 47 is substantially smaller than the dimensions of each light inlet field 44 and each light receiving area 45 measured in the same direction.
  • the thickness of each pane 51 is smaller than the height measured perpendicular to the light entry and exit surface of the light guide means of these.
  • the thickness of the disks 51 can be, for example, approximately 0.15 mm to 0.25 mm.
  • the height of the panes and the entire light guide can be about 1 mm to 2 mm.
  • the thickness of the layers 53 is preferably at most 30% and, for example, approximately or at most 20% of the thickness of the disks 51.
  • the middle plane of the light guide means 33 and / or 43 is understood in the following to mean the plane that is perpendicular to the plane light entry and exit surfaces and runs through the straight line 47.
  • Light that is radiated into a pane 51 parallel to the aforementioned central plane and forms an angle with the surfaces 51a that is at most equal to the angle limit value alpha can pass through the pane without any significant attenuation.
  • light that propagates parallel to the central plane mentioned, but forms an angle greater than alpha with the surfaces 51a is attenuated to a greater or lesser extent.
  • the disks 51 thus form light guides and, moreover, bring about bundling, that is to say non-imaging collimation, at least for light directed parallel to the central plane mentioned.
  • blocks can be formed which have the shapes and dimensions of the light radiation means 27 or light receiving means 29 and a height drawn in FIG. 2 and a height which is a multiple of that in FIG Fig. 1 apparent height of the finished light guide is. From these blocks, platelet-shaped bodies can then be cut off with the heights provided for the light guide means.
  • An ultrasound source 61 shown separately in FIG. 4, is arranged in the housing 25 on the side of the light sources 31 and light receiver 41 facing away from the light radiation area 35 and the light inlet fields 44 and light receiving areas 45.
  • This consists of a piezoelectric element 62 having the shape of a rectangular plate and two sides 63, 64 arranged opposite to each other.
  • the piezoelectric element 62 in the projection shown in FIG. 2 projects at right angles to the light receiving areas on all sides over the light radiation area 35 and the light receiving areas 45.
  • At least one of the electrodes 63, 64 namely, for example, the electrode 64 located on the side of the piezoelectric element 62 facing the light sources 31 and light receivers 41 and also visible in FIG.
  • the electrode 63 is the same as the element 62 and covers it completely, but could also be wave-shaped or meandering and serve as a temperature sensor.
  • ultrasound transmission means are provided in order to transmit ultrasound waves generated by the ultrasound source 61 to the skin 3 of the body 1 during operation.
  • These ultrasound transmission means have a fixed ultrasound transmission and heating element 67. This is formed by a casting resin cast into the housing 75, surrounds the ultrasound source 61 on all sides, forms a solid, compact block that fills all cavities in the housing completely and pore-free, together with this and the various parts of the light radiation means and the light receiving means, and extends to to the plane defined by the edge 25a of the housing 25.
  • the sensor 23 therefore has, on its side intended for contact with the living body 1, a flat, smooth and compact — that is, without exception — boundary and / or contact surface 69 formed by the housing edge 25a, the light guide means 33, 43 and the ultrasound transmission and heating element 67 , which contains and completely surrounds the light radiation area 35 with all light radiation points 34 and all light inlet fields 44 or light receiving areas 45.
  • a thin, for example 0.001 mm to 0.01 mm thick, non-illustrated, gelatinous, ie semi-solid / semi-liquid is completely covered on its boundary and / or contact surface 69 intended to rest against the body 1.
  • a thin for example 0.001 mm to 0.01 mm thick, non-illustrated, gelatinous, ie semi-solid / semi-liquid, is completely covered on its boundary and / or contact surface 69 intended to rest against the body 1.
  • made of polyethylene glycol applied to the light used for measurement, ultrasonic transmission layer.
  • the block mentioned, formed by the ultrasound transmission and heating element 67, the light radiation means 27, the light receiving means 29 and the ultrasound source 61, together with the gelatinous ultrasound transmission layer, enables a good adaptation of the ultrasound wave resistance the ultrasound source 61 to that of the skin 3, so that ultrasound waves generated by the ultrasound source 61 can be transmitted to the skin 3 of the body 1 with at most few reflections.
  • the ultrasound transmission and heating element 67 is also designed such that it absorbs part of the energy generated by the ultrasound source in the form of ultrasound waves and converts it into heat. As a result, the ultrasound transmission and heating element 67 can be heated to a controllable temperature, for example in the range from 37 ° C. to 43 ° C., during operation.
  • the light sources 31, light receiver 41 and the electrodes 63, 64 of the sensor 23 are electrically connected via a flexible cable 71 to a measuring device 73 arranged at a distance from the examined person.
  • a measuring device 73 arranged at a distance from the examined person. This consists of a device with a housing 75, on and / or in which a display device 76, and manually operable switching and / or adjusting elements 77 are fastened.
  • the device 21 has a calibration light distributor 81 shown in FIG. 1 and separately in FIG. 5.
  • the calibration light distributor 81 has a support 82 which is fastened, for example, to the ceiling of the housing 75 in such a way that it is accessible from its surroundings.
  • the support 82 is designed in such a way that the sensor 23, when it is not used for measurement, and in particular for calibration, is temporarily arranged in a defined position on and / or in the support 82 and, for example, inserted into a depression 82a present in it and possibly with it any fastening means not shown, such as locking means, can be releasably attached.
  • the calibration light distributor 81 is provided with light distribution means 83, in order to generate from the various light sources 31 of the sensor 23 during calibration and at the light radiation points 35 to distribute light emitted from the sensor in a predetermined manner to the various light inlet fields 44 or light receiving areas 45 and to feed them to the light receivers 41.
  • the light distribution means 83 have, for example, for each light radiation point 34 belonging to the sensor 23 a light coupling element 85 opposing this during calibration, for each light receiving area 45 belonging to the sensor 23 a light coupling element 86 opposing this during calibration and a number of light guides only partially indicated in FIG. 5 87 each with a glass fiber.
  • Each light guide 87 has an end 87a connected to a light coupling element 85 and an end 87b connected to a light coupling element 86.
  • the light coupling elements 85, 86 can each have a translucent and, for example, crystal-clear body, which is formed, for example, from a casting resin and cast onto a group of light guide ends 87a or 87b.
  • Each light coupling element 85 is connected to each light coupling element 86 by at least one light guide 87 and preferably by several. All pairs of light coupling elements 85, 86 are preferably connected to one another by the same number of light guides.
  • Electronic circuit means 91 are accommodated in the housing 75 of the measuring device 73.
  • the circuit means 91 have, for example, a clock 92 and an evaluation and control device 93, which is formed at least in part by a microprocessor connected to the clock.
  • a light source supply device 94 has inputs connected to the clock generator 92 and to the device 93 and outputs connected via the cable 71 to the light sources 31 of the sensor 23.
  • the light receivers 41 of the sensor 23 are connected via the cable 71 to inputs of a processing and digitizing device 95 belonging to the circuit means 91, which are also connected to the clock generator 92 Has input and outputs connected to device 93.
  • An ultrasound generator 96 has at least one input connected to the evaluation and control device 93 and via the cable 71 to the electrode 63 and to the one connection 64a of the electrode 64.
  • This connection 64a and the other connection 64a of the electrode 64 which also serves as a temperature sensor, are also connected to a temperature measuring device 97, which in turn is also connected to the evaluation and control device 93.
  • One of the manually operable switching and / or actuating elements 77 serves as an on and off switch and is connected to a voltage supply device 98 which supplies the remaining devices of the switching means with the voltages required for their operation.
  • the remaining switching and / or actuating elements 77 are at least partially connected to the evaluation and control device 93.
  • an acoustic alarm signal 99 connected to the device 93 may also be present.
  • the operation of the device 21 will now be explained. Here and assuming that the device is calibrated and that the sensor 23 according to FIG. 1 rests on the surface of the body 1 and is detachably attached to it with adhesive strips or in some other way. Between the sensor 23 and the surface of the skin there is still the thin ultrasound transmission layer already mentioned, made of gelatinous polyethylene glycol, but no space containing air.
  • the evaluation and control device 93 controls the light source feed device 94 in such a way that it supplies the three light sources 31 with pulse sequences which are shifted in time relative to one another, so that the three light sources 31 generate light pulses cyclically.
  • the frequency of these pulse trains is much greater than the pulse or heartbeat frequency and is at least about 100 Hz and for example 1 kHz to 5 kHz.
  • the single ones Light pulses should have a duration of less than a third of the period or cycle duration and should be distributed in such a time that only light of a single wavelength is generated at any point in time. The light pulses generated are then radiated through the light guide means 33 at the light radiation points 34 out of the sensor 23 and into the skin 3 of the body 1.
  • the flow of blood which flows through an artery 13 located in the middle or lower epidermis, is markedly pulsating, the pulsation naturally occurring in time with the heartbeat or the pulse.
  • the blood flow in the arterioles 9 located in the outer or upper dermis is at most little pulsating and practically uniform in the capillary loops 11, in the venules 10 and in the veins 14.
  • the light radiated into the skin 3 and having the specified wavelengths can penetrate into the middle and / or deeper layer of the dermis 6 and in particular also into the blood vessels present therein. As discussed in the introduction, the light in the blood penetrates red blood cells and other blood cells and is redirected by multiple scattering - especially by refraction processes.
  • the red blood cells absorb part of the light, the absorption being dependent on the wavelength of the light and whether or not the hemoglobin of the blood cells contains oxygen. A portion of the light redirected by blood cells can then be scattered back to the surface of the skin 3 and, at the light inlet fields 44 or light receiving areas 45, get into the light guide means and through them into the light receiver 41.
  • the intensity of the light which is scattered by blood, which flows pulsating through arteries 13 located in the middle or lower layer of the dermis, is pulsating in time with the pulse or heartbeat frequency. This is for that Light from all three types of light, ie light with all three wavelengths. As already described in the introduction, the light radiated into the skin 3 is not only scattered by the blood pulsating through at least one artery 13. The light is already scattered in the epidermis 5, especially in the cornea consisting of dead cells.
  • the light receivers 41 convert the light pulses entering them into electrical signals, namely into voltage pulses, the height of which gives a measure of the intensity of the light entering the light receivers.
  • the electrical signals generated by the light receivers i.e. Voltage pulses are then fed to the processing and digitizing device 95. With each light pulse, this generates an electrical signal which, in digital form, gives a measure of the light intensity.
  • the signals generated by the processing and digitizing device 95 are then fed to the evaluation and control device 93.
  • the light entering the light receiver 41 contains a non-pulsating part, ie a part that is constant in time, a part that changes periodically in time with the pulse or heartbeat frequency, and another part that is irregular, that is, more or less stochastic and non-periodically changing part, which is usually known as physiological noise referred to as.
  • the pulse or Heartbeat frequency uses pulsating parts of the light types having the three different wavelengths.
  • the evaluation and control device 93 is designed to assign the light pulses received by each light receiver to the three wavelengths on the basis of their arrival in time.
  • the device 93 is also designed such that it also determines the pulse period and the pulse frequency during operation in cooperation with the processing and digitizing device 95 and performs the function of a digitally working, cumulative filter.
  • the device 93 can, for example, divide each pulse period into a number of equally long time intervals. The division into time intervals is preferably triggered by the intensity maximum that is least influenced by the noise.
  • the device 93 also has a memory in which a memory location is assigned to each of the intervals mentioned for each light receiver. The measured values can then be stored separately in the memory locations for each light receiver 41 during a predetermined number of successive pulse periods and can be accumulated, ie added, for each pulse period.
  • the relationship between the value of the periodically changing signal and the value of the Noise signal increased by cumulation.
  • the accumulation can be carried out depending on the amount of noise and the desired measurement accuracy, for example during about five to one hundred heartbeats.
  • the stored values for each light receiver 43 represent three stair curves. Each of This in turn represents the temporal course of the intensity of a type of light that extends over a period of time and has one of the three wavelengths.
  • the evaluation and control device 93 further determines the stroke of the periodically changing, cumulative light intensity for each of these stair curves, ie the difference between the maximum value and the minimum value of the cumulative light intensity represented by a stair curve. If n cumulations have been carried out, the said difference is equal to 2n times the amplitude of the periodically changing part of the light intensity and thus gives a measure of the amplitude of this periodically changing part of the light intensity.
  • the evaluation and control device 93 can determine the oxygen saturation from the strokes or amplitudes of the light with a wavelength of 800 to 830 nm and the light with a wavelength of approximately 660 nm.
  • the light beams generated by the light sources 31 and passing through the light guide means 33 have radiation axis axes at least approximately at right angles to the surface of the skin when they exit the sensor.
  • the light-guiding means 33 at least largely ensure that light generated by the light sources 31 cannot reach skin areas belonging to the epidermis 5 or dermis 6 without at least one scattering process taking place inside the skin, which areas appear in front of one of the light-receiving areas 45 in a direction perpendicular to the skin surface are located.
  • the between the light sources 31 and the skin 3rd arranged light guide means 33 isolate the skin 3 electrically and also to a certain extent thermally from the light sources 31, so that the skin is not damaged by the heat generated by the light-emitting diodes.
  • the intensity of the light that is scattered in the middle and / or deeper layer of the dermis by blood pulsating through at least one artery 13 and exits the skin again has a maximum at a certain distance from the light radiation area 35.
  • This distance depends on anatomical properties - such as the thickness and structure of the various skin layers, the depth of the arteries 13 and the hematocrit value - and thus on the individual properties of the person examined and the selected measuring point.
  • the distance depends on variables that can be changed over time, such as the hematocrit value already mentioned and the blood flow, the latter being able to be influenced, inter alia, by the muscle fibers present in the walls of the arteries 13 and by the anastomoses 15.
  • the light scattered back to the skin surface can exit the skin in different directions.
  • the light guide means 43 arranged in front of the light receivers 41 and forming the light inlet fields 44 and light receiving areas 45 only allow the scattered light, the directions of which are parallel to the sectional plane of FIG. 1, to reach the light receivers that form an angle with a straight line that is perpendicular to the skin surface is at most equal to the selected angle limit alpha and thus, for example, is at most 20 °.
  • the light guide means 43 therefore contribute to the fact that light scattered in relatively deep layers of the skin 3 reaches the light receivers 41.
  • the light guide means 43 further isolate the skin 3 electrically and to a certain extent also thermally against the light receiver 41.
  • the microprocessor of the evaluation and control device 93 is designed and programmed in such a way that it determines the light receiver in which the light intensities meet a predetermined selection criterion.
  • the microprocessor can, for example, determine the light receiver in which the amplitude of the periodically changing part of the light has a maximum with the wavelength of 800 to 830 nm and therefore in the vicinity of the isobestic wavelength.
  • the microprocessor then exclusively uses the light intensities measured by this light receiver and represented by electrical signals and pulsing in time with the pulse frequency for the determination of the oxygen saturation.
  • the microprocessor thus selects the light inlet field 44 located in front of the relevant light receiver or the light receiving area 45 which is identical to this, as the utilization area and only utilizes the light entering the sensor for measuring the oxygen saturation.
  • the signals could instead be used by the light receiver for the determination of the oxygen saturation at which the ratio between the stated amplitude and the maximum value or the mean value or the minimum value of the total light, which has approximately the isobestic wavelength, has a maximum. It should be noted that all of these different selection criteria are normally met for one and the same light receiver.
  • the cheapest light receiving point can be located approximately in the middle between two adjacent light inlet fields 44 or light receiving regions 45, so that the predetermined selection criterion for two light inlet fields 44 is approximately equally well fulfilled. It may even happen that more than two, for example three, light inlet fields 44 result in approximately optimal measurement conditions.
  • the microprocessor can now possibly be designed and programmed in such a way that in such a case it adds the light intensities measured by two or even more light receivers for each type of light, ie wavelength, and uses them to determine the oxygen saturation. This means that for the determination of the oxygen saturation a utilization area is selected or determined which contains two or possibly even more light inlet fields 44 or light reception areas 45 which follow one another along the straight line 47.
  • the size of the recycling area, in which the light entering the sensor is used to measure the saturation, can to a certain extent be changed electronically. However, normally only the light entering the sensor through part of the light inlet fields and never the light entering the sensor through all light inlet fields 44 are used for the determination of the oxygen saturation.
  • the elimination of undesired scattered light achieved with the light guide means 33, 43 and the selection made in the manner described in the manner described at least one inexpensive light receiver 41 and at least one inexpensive light reception area associated with this for determining the oxygen saturation means that a great deal of time can be achieved in all measurements periodically changing light, scattered by arterial blood, in time with the pulse or heartbeat frequency reaches the selected light receiver. This in turn ensures high measurement accuracy.
  • the ultrasound source 61 generates pulsed ultrasound waves during the measurement processes and possibly even before the actual start of the measurement. Part of the wave energy is absorbed by the ultrasonic transmission and heating element 67 and converted into heat. The energy portion converted into heat is preferably about 30% to 70% of the total energy supplied to the ultrasound transmission and heating element 67 in the form of ultrasound waves.
  • the converted into heat Energy heats the ultrasound transmission and heating element 67 to the temperature already indicated, which is above the temperature normally present on the skin surface.
  • the temperature of the ultrasound transmission and heating element 67 is determined by the electrode 64, which also serves as a temperature sensor, in cooperation with the temperature measuring device 97. This feeds the microprocessor to the evaluation and control device 93 a digital signal representing the value of the temperature.
  • the device 93 controls the ultrasound generator 96 in such a way that the measured temperature is kept at a predetermined setpoint.
  • the temperature can be regulated, for example, by regulating the pulse width of the generated ultrasonic wave pulses.
  • the heated ultrasound transmission and heating element 67 supplies heat to the skin 3 by conduction. Furthermore, ultrasound waves are also transmitted to the skin and absorbed therein. This absorption takes place above all in the skin layers containing blood, living cells, so that the inner layers of the skin are heated directly by the ultrasound waves. Both the heat conduction and the ultrasonic wave transmission take place partly through the light sources, light receivers and light guide means. Incidentally, the heat generated in the light sources and light receivers from electrical energy can also contribute to heating the skin.
  • the continuous heating of the skin by heat conduction and by ultrasound waves absorbed inside the skin enables the area of the skin used to measure the oxygen saturation to be heated to a relatively high, fairly uniform temperature which increases the blood circulation, without any area of the skin being damaged by overheating .
  • the block which consists of the ultrasound transmission and heating element 67 and the components embedded in it, extends to the plane defined by the housing edge 25a, it is necessary to measure, besides the thin one mentioned, between the sensor and the skin layer to be attached made of polyethylene glycol, no such and also no other, semi-solid, and to some extent flowable or liquid material serving for ultrasound transmission, are introduced into any cavities.
  • the use of the sensor 23 is therefore very simple and in particular simpler than the use of the sensors commented on in the introduction and known from US-A-4,890,619.
  • the third type of light that is to say the light generated by the third light source 31 and having a wavelength of approximately 575 nm, is relatively strongly absorbed by oxygen-free, oxygen-containing and carbon monoxide-containing hemoglobin. Furthermore, the light absorption coefficients of oxygenless and oxygenated hemoglobin at this wavelength are quite similar in magnitude.
  • the ratio between the amplitude of the intensity of the scattered light of the third type of light that changes periodically in time with the pulse frequency and the maximum value or mean or minimum value of the intensity of the total scattered light of the third type of light therefore gives a measure of the relative size of the hemoglobin that is largely independent of the gas saturation Volume of blood that is present in the section of skin into which the light penetrates.
  • the evaluation and control device 93 is designed to determine the latter ratio.
  • the device 93 may be able to determine absolute values for the relationship between the blood volume and the total volume of the detected skin section based on the formulas determined by model calculations and / or on value assignments stored in tabular form as well as calibrations. The determination of the size giving a measure of the blood volume can be carried out either with or without heating the skin.
  • the light of the third type of light is preferably used only for the determination of the blood volume which reaches the sensor through the utilization range selected for the determination of the oxygen saturation.
  • the display device 76 displays the value of the oxygen saturation, which is denoted by SA, the pulse frequency which is denoted by P, and a value which is denoted by BV, which is a measure of the blood volume.
  • the switching and / or adjusting elements 77 make it possible to enter at least one upper and / or lower limit value for the oxygen saturation and possibly for other measured variables. Exceeding or falling below such a limit value can then be signaled optically by the display device 76 and / or acoustically by the acoustic alarm device 99.
  • the device 21 is calibrated by the manufacturer before delivery. Under certain circumstances, however, the intensities of the light pulses generated by the three light sources or the sensitivities of the different light receivers for the different light wavelengths can change. Sensitivity is understood here to mean the relationship between the height of the electrical voltage pulse generated by a light receiver and the intensity of a light pulse entering the light receiver.
  • the sensor 23 When the sensor 23 is not used for measurement, it can be temporarily held in the recess 82a of the support 82 of the calibration light distributor 81.
  • the light radiation points 35 and light receiving areas 45 of the sensor 23 then face the light coupling elements 85 and 86 of the calibration light distributor 81 and abut them, for example.
  • a user can then use the electronic circuitry bring into a calibration mode by manually actuating at least one of the switching and / or actuating elements 77.
  • the evaluation and control device 93 controls the light source feed device 94 such that each of the three light sources 31 generates at least one light pulse.
  • a part of the light emitted from the sensor at the light radiation points 34 is then distributed by the calibration light distributor 81 to the various light inlet surfaces 44 or light receiving areas 45 of the sensor and is fed there to its light receivers 41.
  • Each light receiver then generates a voltage pulse for each of the three types of light.
  • the heights - ie voltage values - of these pulses and / or values derived therefrom by the microprocessor were then stored as calibration values in memory locations of a memory belonging to the evaluation and control device 93 until the next calibration.
  • the device can be brought into the normal operating mode by manually actuating at least one of the switching and / or actuating members 77 or by a switching member actuated by removing the sensor 23 from the support 82. In this, the newly determined and stored calibration values are then used to utilize the measured light intensity values. Such calibrations can ensure that the device 21 still delivers accurate measurement results even after prolonged use.
  • the device 121 shown in FIG. 7 has a sensor 123 partly corresponding to the sensor 23 and a measuring device 173 corresponding partly to the measuring device 73. Unless otherwise specified below, the two devices can be designed similarly, with parts corresponding to one another identical reference numerals are designated. However, the device 121 has light-emitting means 127 which are designed differently than the light-emitting means 27 of the device 21. The light-emitting means 127 have for generating Light of the various types of light required requires at least one light source 131 arranged outside the sensor 123 in the housing 75 of the measuring device 173.
  • the light radiation means 127 can, for example, analogously to the light radiation means 27, have a plurality of light sources each consisting of a semiconductor diode, each of which generates light with a different wavelength . If the or each light source 131 generates light with different wavelengths - ie with a broad spectrum - during operation, the light radiation means can furthermore have at least one interference filter, which filters out and transmits the light from the generated light spectrum that exactly the desired wavelength for each type of light having.
  • the measuring device 173 also has a light collector 132 in order to collect the light generated by the at least one light source 131 and to feed it to the one end held in and / or on the housing 75 by elongated, flexible light guide means 133 which have at least one glass fiber.
  • the other end of the light guide means 133 is connected to the sensor 123.
  • This can, for example, have a groove on its side lying against the body 1 during measurement, in which the last-mentioned end of the light-guiding means 133 and a metallic reflector 134 are arranged, the end of the light-guiding means inclined 45 ° relative to the sensor side resting on the body 1 133 facing reflector surface 134a.
  • the light-guiding means 133 define a light radiation region 135 which can be seen in FIG. 8 and in which the light can be radiated out of the sensor 123 and into the body 1.
  • the space between the end of the light guide means 133 fastened in the sensor and the reflector 134 is filled, for example, with a translucent material 136.
  • the light collector 132, the light guide means 133, the reflector 134 and the material 136 together form light transmission means which the light generated by the at least one light source 131 can be transmitted to the light radiation region 135.
  • the light of all types of light generated can be sequentially at one and the same light radiation location - i.e. through one and the same surface - of the light radiation region 135 are emitted out of the sensor 123.
  • the light radiation area 135 can, for example, be circular in a plan view of the side of the sensor which is in contact with the body 1 during measurement, and in the plan view mentioned a very small, preferably at most 2 mm, for example at most 1 mm or even only at most 0.5 mm in all directions amount.
  • the light guide means 133 like the light guide means 33, have a collimating effect which directs the light rays more or less in parallel.
  • the light receivers 41 of the devices 21 and 121 which consist of separate photo semiconductors, can be replaced by an integrated circuit, as shown schematically in FIG. 9 and designated by 240.
  • the integrated circuit 240 has a straight row of photo semiconductors, namely photo diodes, each of which forms a light receiver 241.
  • the sensor containing the integrated circuit 240 can, for example, still have light guide means 43, not shown in FIG. 9, which are arranged analogously to the devices 21 and 121.
  • Each light receiver 241 deninishes on the side of the sensor which is in contact with the body to be examined during measurement a light inlet field 244.
  • the light inlet fields 244 can be, for example, square or rectangular and separated by narrow spaces.
  • the integrated circuit 240 can contain a relatively large number, for example at least 100, of photodiodes.
  • the microprocessor of the electronic circuit means connected to the integrated circuit can therefore be used for Example be designed to add the light intensities measured by a group in the longitudinal direction of successive light receivers 241 before or after the cumulative filtering and to assign a light receiving area 245 to each of these groups. All light receiving areas 245 can contain an equal number of light inlet fields 244.
  • the light intensities are first measured separately for each light receiving area 245. Then, analogously to the device 21, one of the light receiving areas 245 is selected as the utilization area, for example, and the light entering or entering the sensor is used to determine the oxygen saturation.
  • the microprocessor for determining the oxygen saturation can possibly also add the light intensities measured by two or more groups of light receivers and thus vary the size of the utilization area in which the light is used in an analogous manner during measurement, as has already been explained for the light receivers 41 .
  • the facilities can be expanded and / or modified in other ways.
  • the devices can be designed, for example, to also determine and display the carbon monoxide saturation of the blood.
  • the carbon monoxide saturation can be determined, for example, from the intensity ratio between the third and the second type of light. Possibly, light pulses of a fourth type of light with a wavelength that is shorter than that of the first, second and third type of light can be generated and measured for the determination of the carbon monoxide saturation.
  • Carbon monoxide saturation can be measured by utilizing the intensities of light that reaches the sensor in the same utilization range as that used to determine oxygen saturation Light. The value of the measured carbon monoxide saturation can, for example, be displayed in percent.
  • the light sources - particularly if they are arranged outside the sensor - can consist of different types of lasers instead of the light-emitting or laser diodes already mentioned.
  • the light-guiding means 33, 43 can be replaced by light-guiding means which, instead of flat glass panes, have a bundle of short, side-by-side, glued or otherwise firmly connected sections of glass fibers which serve as light guides. Such light guide means then result in collimation that is rotationally symmetrical to the axes of the fibers.
  • the light-guiding means 33 can be formed together with the light-guiding means 43 from a single, coherent, platelet-shaped body having disks or fibers made of glass.
  • the light guide means 33 located in front of the light sources 31 can also be formed by a single, for example plate-shaped piece of glass. With such a design of the light guide 31, it is advantageous to mirror the edge surfaces of the glass piece and / or to form the ultrasonic transmission and heating element 67 surrounding the edge surfaces from an opaque casting resin.
  • the light receiving means can possibly be equipped with two or three or possibly even more rows of light receivers arranged side by side.
  • the light-guiding means belonging to the light-receiving means can then be arranged for one of the light-receiving rows according to FIG. 3 and at right angles to the skin surface bDiscs serving as light guides or glass fibers perpendicular to the skin surface.
  • the light-guiding means assigned to the other light receivers can have disks or fibers which, in a sectional or projection plane parallel to the sectional plane of FIG. 1, form an angle different from 90 ° with the skin surface and the straight line 47 and away from the skin surface to the left - ie are inclined towards the light sources.
  • the angle formed by the disks or fibers with the straight line 47 can be in a cutting or projection plane parallel to the sectional plane of FIG. 1 in one row 90 °, in another row approximately 25 ° up to 45 ° and about 50 ° to 70 ° for the last row.
  • a series of light receivers can also be provided, to which light guide elements are assigned, which have slices or fibers inclined to the right in a section corresponding to FIG. 1 away from the surface of the skin, the angle formed with the straight line 47 being at least 60 °.
  • the evaluation and control device 93 can be designed in order to select a utilization area with at least one light-receiving area for the determination of the oxygen saturation Both the distance from the light radiation area and the main transmission direction of the light guide means - ie the angle of the light guide with the skin surface and the straight line 47 - is the most favorable.
  • the light receivers and the light receiving areas can correspond to the skin surface in one of FIGS. 2 or 8 right-angled projection to be curved concentrically to the center of the light radiation area and to have the shape of circular ring sectors which all extend over the same central angle. Furthermore, there is the possibility, in a plan view corresponding to FIG. 2 or 8, to provide light receiving areas and light receivers arranged on both sides of the light radiation area and with respect to them mirror-symmetrically arranged.
  • the side or contact surface of the sensor which is in contact with the body 1 when measuring instead of being slightly concave in a sectional plane, the radius of curvature being, for example, at least or approximately 50 cm.
  • the row formed by the light inlet fields and light receiving areas should then preferably still be straight in a plan view of the side of the sensor which is in contact with the body to be examined during measurement.
  • the sensor can possibly even be a little bendable, so that its side or surface that is in contact with the body to be examined during measurement can adapt to the body surface.
  • the ultrasound source 61 may possibly be omitted.
  • the calibration light distributor can have at least one light reflector and / or a light scattering element in order to distribute light radiated against it by the light radiation means to the light inlet fields and light receiving areas of the sensor.
  • a light scattering element can, for example, have a body with a matrix made of glass, in which a multiplicity of small particles, which consist of another glass or another material and cause light scattering, are dispersed.

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Claims (17)

  1. Dispositif pour la mesure d'au moins une saturation en gaz, notamment pour la saturation en oxygène du sang se trouvant dans un corps vivant (1) avec un détecteur (12, 123) prévu pour être appliqué sur le corps (1), avec des moyens (27) de rayonnement de lumière pour rayonner dans au moins une zone (35) de rayonnement de lumière, à partir du détecteur (23, 123) sur le corps (1), de la lumière comportant différentes longueurs d'ondes et avec des moyens (29) de réception de la lumière, tandis que le détecteur (23, 123) comporte des zones réceptrices de la lumière (45, 245) se trouvant à différentes distances de la zone (35, 135) de rayonnement de la lumière, et dans lesquelles la lumière récurrente dispersée sur le corps (1) peut parvenir aux moyens de réception de la lumière (27), ces derniers étant conçus pour déterminer, pour chaque zone réceptrice de la lumière (45, 245) l'intensité de la lumière qui leur parvient par elle, et des moyens de branchement (91) reliés aux moyens (29) de réception de la lumière étant prévus pour déterminer, à partir des intensités de lumière déterminées pour les différentes longueurs d'ondes, la saturation en gaz au moins unique,
       dispositif caractérisé en ce que les moyens de branchement (91) sont conçus pour sélectionner sur la base d'un critère une zone d'utilisation à partir des zones réceptrices de lumière (45, 245), et pour n'utiliser que la lumière arrivant aux moyens de réception de la lumière (29) dans la zone d'utilisation sélectionnée pour la détermination d'au moins une saturation en gaz.
  2. Dispositif selon la revendication 1, caractérisé en ce que les moyens de branchement (91) sont conçus pour utiliser, pour la détermination de la saturation en gaz, une partie de la lumière reçue, changeant périodiquement dans le temps avec la fréquence de pulsation du sang circulant à travers le corps (1), et pour déterminer la zone d'utilisation de façon que celle-ci comprenne la zone réceptrice de lumière (4b, 24b) pour laquelle l'amplitude de l'intensité de la, partie mentionnée de la lumière comportant une des longueurs d'onde, ou bien le rapport entre cette amplitude et la valeur maximale ou la valeur moyenne, ou la valeur minimale de l'intensité de la totalité de la lumière reçue dans la zone réceptrice de lumière (45, 245) en question et comportant la longueur d'onde mentionnée, est au maximum.
  3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que les moyens de réception de la lumière (29) comportent plusieurs récepteurs de lumière (41) pour la mesure séparée des intensités de la lumière arrivant sur eux, en ce que à chaque zone réceptrice de lumière (45, 245) est associé au moins un récepteur de lumière (41, 241) et en ce que les moyens de branchement (91) sont conçus pour associer à la zone d'utilisation au moins un et au plus, une partie des récepteurs de lumière (41, 241), les récepteurs de lumière (41, 241) étant de préférence constitués de photosemi-conducteurs.
  4. Dispositif selon une des revendications 1 à 3, caractérisé en ce que le détecteur (23, 123) comporte au moins trois, aussi bien que de préférence au moins cinq zones réceptrices de lumière (45, 245) qui sont à des distances différentes de la zone (35, 135) de rayonnement de la lumière.
  5. Dispositif selon la revendication 4, caractérisé en ce que les zones réceptrices de lumière (45, 24b) forment une rangée qui, au moins sur une vue de dessus, sur le côté du détecteur (23, 123) prévu pour être appliqué sur le corps (1), est rectiligne, en ce que chaque zone réceptrice de lumière (45, 245) a au moins un champ d'entrée de la lumière (44, 244), à travers lequel la lumière peut arriver dans les moyens de réception de la lumière (29), et en ce que l'extension mesurée en direction longitudinale de la rangée, de chaque champ d'entrée de la lumière (44, 244) est supérieure à la moitié et est de préférence au moins égale aux deux tiers de la distance des points médians de deux champs d'entrée de la lumière (44, 244) voisins l'un de l'autre.
  6. Dispositif selon la revendication 5, caractérisé en ce que l'extension de la zone de rayonnement de la lumière (35, 135) mesurée parallèlement à la direction longitudinale de la rangée des zones réceptrices de la lumière (45, 245) est d'au plus 2 mm et de préférence d'au plus 1 mm, tandis que l'extension de la zone de rayonnement de la lumière (35, 135) est de préférence au plus de 6 mm.
  7. Dispositif selon une des revendications 1 à 6, caractérisé en ce que les moyens de rayonnement de la lumière (27) comportent des sources de lumière (31) disposées dans le détecteur (23), et qui comportent des espèces de lumière pour produire les différentes longueurs d'ondes, tandis que les sources de lumière sont de préférence constituées de diodes semi-conductrices.
  8. Dispositif selon une des revendications 1 à 6, caractérisé en ce que les moyens de rayonnement de la lumière (127), pour produire de la lumière de différentes longueurs d'ondes, comportent au moins une source de lumière (131) disposée en dehors du détecteur (123), qui par des moyens de transmission de la lumière (132, 133, 134, 136) est reliée au détecteur (123) de façon que les espèces de lumière comportant les différentes longueurs d'ondes puissent être rayonnées séquentiellement hors du détecteur (123) par une seule et même surface de la zone de rayonnement (135) de la lumière.
  9. Dispositif selon la revendication 7 ou 8, caractérisé en ce que les moyens de rayonnement de la lumière (27, 127) comportent des moyens conducteurs de la lumière (33, 133) disposés entre chaque source de lumière (31, 131) et la zone de rayonnement de la lumière (35).
  10. Dispositif selon une des revendications 1 à 9, caractérisé en ce que les moyens (29) de réception de la lumière comportent des moyens conducteurs de la lumière (43) disposés entre les zones réceptrices de la lumière (45, 245) et les récepteurs de lumière (41, 241).
  11. Dispositif selon la revendication 9 ou 10, caractérisé en ce que les points médians de la zone (35, 135) de rayonnement de la lumière et des zones réceptrices de la lumière (45, 245) se situent sur une ligne médiane (47), qui au moins dans une vue de dessus sur le côté du détecteur (23, 123) prévu pour s'appliquer sur le corps (1) est rectiligne, et en ce que les moyens conducteurs de lumière (33, 43) comportent des conducteurs de lumière formés de plaques planes (51) qui, dans la vue de dessus précitée, sont à angle droit par rapport à la ligne médiane (47).
  12. Dispositif selon une des revendications 1 à 11, caractérisé en ce que les moyens de branchement (91) sont prévus pour subdiviser la durée des périodes de pulsation en plusieurs intervalles de temps et pour cumuler séparément pour les différentes longueurs d'ondes, pendant plusieurs périodes de pulsation, les intensités de la lumière reçue par les moyens récepteurs de lumière (27) pendant les différents intervalles de temps.
  13. Dispositif selon une des revendications 1 à 12, caractérisé en ce que le détecteur comporte au moins une source d'ultrasons (61) et des moyens de transmission d'ultrasons, pour transmettre les ondes ultrasonores produites par la source d'ultrasons (61) au cors vivant (1), en ce que les moyens de transmission d'ultrasons comportent un corps (67) de transmission d'ultrasons, qui forme une surface d'application (69) prévue pour être appliquée sur le corps vivant (1) et qui entoure, au moins pour l'essentiel, la zone de rayonnement de la lumière (35, 135) ainsi que toutes les zones réceptrices de la lumière (45, 245).
  14. Dispositif selon la revendication 13, caractérisé en ce que le corps (67) de transmission d'ultrasons est prévu, pour convertir en chaleur 30 % à 70 % de l'énergie qui lui est amenée sous la forme d'ondes ultrasonores et pour la transmettre au moins partiellement par conduction thermique au corps vivant (1).
  15. Dispositif selon la revendication 13 ou 14, caractérisé en ce que la source d'ultrasons (61) comporte une électrode (64) servant à produire les ondes ultrasonores et qui est constituée par une résistance électrique servant également de sonde de température.
  16. Dispositif selon une des revendications 1 à 15, caractérisé par un répartiteur de lumière étalon (81) qui pour étalonner le dispositif peut être tourné vers la zone (35, 135) de rayonnement de la lumière ainsi que vers les zones réceptrices de la lumière (45, 245) et amener dans celles-ci aux moyens récepteurs de la lumière, la lumière qui lui est amenée à partir des moyens (27, 127) de rayonnement de la lumière dans la zone de rayonnement de la lumière (35, 135).
  17. Dispositif selon une des revendications 1 à 16, caractérisé en ce que les moyens (27, 127) de rayonnement de la lumière sont prévus pour produire au moins trois espèces de lumière monochromatique, comportant chacune une autre longueur d'onde, et en ce que, une de ces espèces de lumière a une longueur d'onde de 500 nm à 600 nm et sert à déterminer une grandeur qui donne une mesure pour le volume du sang se trouvant dans une partie du corps vivant (1).
EP92810583A 1991-08-12 1992-07-31 Dispositif permettant de déterminer la concentration d'au moins un composé gazeux en particulier la teneur en oxygène du sang Expired - Lifetime EP0527703B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH2372/91 1991-08-12
CH237291 1991-08-12

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EP0527703A1 EP0527703A1 (fr) 1993-02-17
EP0527703B1 true EP0527703B1 (fr) 1995-06-28

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EP92810583A Expired - Lifetime EP0527703B1 (fr) 1991-08-12 1992-07-31 Dispositif permettant de déterminer la concentration d'au moins un composé gazeux en particulier la teneur en oxygène du sang

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US (1) US5299570A (fr)
EP (1) EP0527703B1 (fr)
JP (1) JP2588670B2 (fr)
AT (1) ATE124225T1 (fr)
DE (1) DE59202684D1 (fr)

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DE59202684D1 (de) 1995-08-03
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US5299570A (en) 1994-04-05
ATE124225T1 (de) 1995-07-15

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